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RegeneRx Receives "Decision to Grant" European Patent For Treatment of Peripheral Neuropathy

Published: Mar 12, 2018

ROCKVILLE, Md., March 12, 2018 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that the European Patent Office has issued a Decision to Grant a new patent for treating patients with peripheral neuropathy using Thymosin beta 4 (Tβ4). Tβ4 is the active pharmaceutical ingredient in RegeneRx's proprietary drug candidate, RGN-352, a first-in-class injectable formulation designed for systemic administration.

An estimated 20 million people in the United States have some form of peripheral neuropathy, a condition that develops as a result of damage to the peripheral nervous system -- the vast communications network that transmits information between the central nervous system (the brain and spinal cord) and every other part of the body. (Neuropathy means nerve disease or damage.) Symptoms can range from numbness or tingling, to pricking sensations (paresthesia), or muscle weakness. Areas of the body may become abnormally sensitive leading to an exaggeratedly intense or distorted experience of touch. Severe symptoms may include burning pain (especially at night), muscle wasting, paralysis, or organ or gland dysfunction. Diabetes mellitus is a common cause of peripheral neuropathy.

RegeneRx in-licensed the intellectual property relating to the use of Tβ4 from the Henry Ford Hospital System in Detroit, MI based on work performed by Dr. Michael Chopp and his colleagues.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.

RegeneRx, through its U.S joint venture, ReGenTree LLC, recently completed patient enrollment and treatment in its second Phase 3 clinical trial in approximately 600 patients with dry eye syndrome, reported positive clinical results with no safety issues, and has scheduled a meeting with the U.S. FDA. ReGenTree is also conducting a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK) targeted for completion in 2018. Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.

RGN-352, the Company's Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke.

RGN-137, also designated an orphan drug in the U.S., is the Company's Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition. The Company's licensee, GtreeBNT, is sponsoring a phase 3 clinical trial in the U.S. and is expected to initiate the study in 2018.

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any notices or patents issued by any government patent authority in any country, or licenses held by the Company, or patent applications filed by the Company, including this most recent issued patent for dry eye syndrome in the United States, or any current or future clinical trials will result in approved products or future value. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2016, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.